BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4801306 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59812
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DISPLACEMENT, PRIME AND EXCESSIVE NO DELIVERY TESTS. NO EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE PUMP HAD A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE LCD WINDOW, AND A SCRATCHED RESERVOIR TUBE WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING BASAL DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVELS WERE NOT INCLUDED IN THE REPORT. CUSTOMER REPORTS THE ALARM WAS RESOLVED BY A COMPLETE SET CHANGE. PRODUCT IS BEING RETURNED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346372 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR